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Allomatrix Injectable Putty in Distal Radius Fractures

This study has been completed.
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00274378
First received: January 6, 2006
Last updated: July 29, 2009
Last verified: July 2009
History of Changes
  Purpose

Allomatrix is a combination of Demineralized Bone Matrix with a binding medium of calcium sulfate hemihydrate and carboxymethylcellulose. Allomatrix combines the osteoinductive capacity of DBM with the osteoconduction and controlled resorption of surgical grade calcium sulfate.

Unstable fractures of the distal radius do not resist displacement once it has been manipulated into an anatomical position.

There is a parallel between the quality of the anatomic result and the residual capacity of the wrist, except in older, low demanding patients.

Injectable osteoconductive cements have been introduced to fill voids in metaphyseal bone and may provide a better stability around hardware in osteoporotic bone and help maintain reduction of fracture fragments.Moreover, a product like ALLOMATRIX could accelerate and improve bone healing and fracture stability by its osteoinductive properties. However, the clinical significance of these new bone graft materials still have to be proven in a randomised controlled study set-up.


Condition Intervention Phase
Radius Fractures
 Device: ALLOMATRIX injectable putty in distal radius fractures
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Allomatrix Injectable Putty in Distal Radius Fractures. Protocol for a Randomised, Controlled Clinical Study in Unstable Fractures of the Distal Radius

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • Hand ability: self-assesment questionnaire ABILHAND and DASH

Secondary Outcome Measures:
  • Bone mineral density
  • Radiological evaluation
  • Hand impairment (strength, sensibilty, mobility)

Estimated Enrollment: 50
Study Start Date: June 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unstable distal radius fracture

Exclusion Criteria:

  • associated traumatic lesions
  • associated severe pathological conditions
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274378

Locations
Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Wright Medical Technology
Investigators
Principal Investigator: Olivier BARBIER, MD Cliniques Universitaires St-LUC, 1200 Brussels
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00274378     History of Changes
Other Study ID Numbers: Allomatrix radius UCL
Study First Received: January 6, 2006
Last Updated: July 29, 2009
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Université Catholique de Louvain:
radius fracture
fracture fixation
homologous bone transplantation

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on June 17, 2013